Afamelanotide in Patients Suffering With Acne Vulgaris

• Sponsor: Clinuvel Pharmaceuticals Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04943159
• Collaborator: (none)
• Enrollment: 3
• Arms: 2
• Actual Duration (Months): 6.4

Study Details

Study Description

Brief Summary

This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Afamelanotide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne Vulgaris
• Actual Study Start Date: Aug 24, 2010
• Actual Primary Completion Date: Mar 8, 2011
• Actual Study Completion Date: Mar 8, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Afamelanotide group A	Drug: Afamelanotide; Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.
Experimental: Afamelanotide group B	Drug: Afamelanotide; Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.

Outcome Measures

Primary Outcome Measures

1. The Change in Number of Facial Inflammatory Acne-related Lesions. [From baseline to Day 56.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;

• Chronic course of acne vulgaris;

• Acne-related lesions both on the face, chest and back;

• Indication for treatment of acne vulgaris;

• Aged 18-30 years (inclusive);

• Fitzpatrick skin types I-III;

• Providing written Informed Consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

• Female subjects;

• Diagnosis of severe acne vulgaris;

• Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant;

• Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;

• Use of oral antibiotics for acne within 4 weeks prior to the first dose;

• Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose;

• Use of systemic retinoids within 6 months prior to the first dose;

• Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;

• Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose;

• Use of tanning booths or lamps within 1 week prior to the first dose;

• Active skin disease that may interfere with evaluation;

• Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;

• Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Clinuvel Pharmaceuticals Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinuvel Pharmaceuticals Limited
• ClinicalTrials.gov Identifier: NCT04943159
• Other Study ID Numbers: CUV100
• First Posted: Jun 29, 2021
• Last Update Posted: Oct 26, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Acne Vulgaris; Afamelanotide

Study Results

Participant Flow

Pre-assignment Detail	A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.

Arm/Group Title	Afamelanotide (Pooled Analysis)
Arm/Group Description	Group A are administered afamelanotide implant on Days 0, 21 and 42; Group B are administered afamelanotide implant on Days 0 and 28.
Period Title: Overall Study
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Afamelanotide (Pooled Analysis)
Arm/Group Description	Group A are administered afamelanotide implant on Days 0, 21 and 42; Group B are administered afamelanotide implant on Days 0 and 28.
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	3 100%

Outcome Measures

1. Primary Outcome

Title	The Change in Number of Facial Inflammatory Acne-related Lesions.
Time Frame	From baseline to Day 56.

Outcome Measure Data

Analysis Population Description

A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.

Arm/Group Title	Afamelanotide (Pooled Analysis)
Arm/Group Description	Group A are administered afamelanotide implant on Days 0, 21 and 42; Group B are administered afamelanotide implant on Days 0 and 28.
Measure Participants	3
Baseline	46 (30.3)
Day 56	23.7 (15.6)

Adverse Events

Adverse Event Reporting Description	A pooled analysis of all the patients treated by afamelanotide (group A and group B) was conducted as only 3 patients were recruited in the study (2 in group A and one in group B) due to difficulties in recruitment.
Arm/Group Title	Afamelanotide (Pooled Analysis)
Arm/Group Description	Group A are administered afamelanotide implant on Days 0, 21 and 42; Group B are administered afamelanotide implant on Days 0 and 28.
All Cause Mortality
	Afamelanotide (Pooled Analysis)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Afamelanotide (Pooled Analysis)
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Afamelanotide (Pooled Analysis)
	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)
General disorders
Fatigue	1/3 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.